Ge Tonoport V User Manual

GE Healthcare

TONOPORT V

Ambulatory Blood Pressure System

Firmware Version 2.1

Operator’s Manual

2001589-085 ENG Revision F

Note

The information in this manual only applies to TONOPORT V, firmware version 2.1. It does not apply to earlier
firmware versions.

Due to continuing product innovation, specifications in this manual are subject to change without notice.

CASE™ is a trademark owned by GE Medical Systems Information Technologies GmbH, a General Electric
Company going to market as GE Healthcare.

© 2009–2016 General Electric Company. All rights reserved.

2 TONOPORT V 2001589-085 Revision F

Contents

1 Application, Safety Information 6

2 Controls and Indicators 10

3 Setup 12

4 Application 17

5 Data Output 21

6 Error Codes 22

7 Software Installation 23

8 Cleaning, Maintenance, Disposal 25

9 Technical Specifications 27

10 Order Information 28

11 Appendix - Electromagnetic Compatibility (EMC) 29

Revision History

This manual is subject to the GE Healthcare change order service. The revision code, a letter that follows the

document part number, changes with every update of the manual.

Part No./Revision Date Comment

2001589-085 Revision A 2009-05 Initial release

2001589-085 Revision B 2010-04 General Information: modifications in 3rd

paragraph

Section 1.3: additional information concerning the

ingress of liquids

Chapter 2: four symbols added

Chapter 3: additional information concerning

alternative charger

2001589-085 Revision C 2011-10-31 CardioSys was removed globally

Chapters 1.1, 5 and 7: interface restrictions for

CASE/CardioSoft were added

Chapter 2: relevant battery charger symbols were

added

Chapter 7: CardioSoft version 6.7 for Windows 7

and reference to the “CASE-CS” folder were added

Chapter 9: measuring range for mean pressure was

corrected to '50 to 250 mmHg'

2001589-085 Revision D 2014-01-31 Changes on pages 4, 5, 11, 12, 23, and 24.

2001589-085 Revision E 2015-05-07 Changes on pages 8, 17, and 27.

2001589-085 Revision F 2016-07-12 Changes on pages 4, 11, and 28.

2001589-085 Revision F TONOPORT V 3

General Information

General Information

 The product TONOPORT V bears the CE marking

CE-0482 (notified body MEDCERT GmbH)

indicating its compliance with the provisions of the

Council Directive 93/42/EEC about medical devices

(including amendment 2007/47/EC) and fulfills the

essential requirements of Annex I of this directive. It

has an internal power source and is an MDD class IIa

device. The device fulfills the requirements of the

Directive 2011/65/EU of the European Parliament

and of the Council.

 It has a type BF applied part.

 The product fulfills the requirements of the standard

EN/IEC 60601-1 "Medical Electrical Equipment, Part

1: General Requirements for Basic Safety and

Essential Performance" as well as the electromagnetic

immunity requirements of the standard EN/IEC

60601-1-2 "Medical electrical equipment – Collateral

standard: Electromagnetic compatibility –

Requirements and tests" and applicable amendments.

 The radio-interference emitted by this product is

within the limits specified in CISPR11/EN 55011,

class B.

 The CE marking covers only the accessories listed in

the "Order Information" chapter.

 This manual is an integral part of the equipment. It

should be available to the equipment operator at all

times. Close observance of the information given in

the manual is a prerequisite for proper equipment

performance and correct operation and ensures

patient and operator safety. Please note that

information pertinent to several chapters is given

only once. Therefore, carefully read the manual

once in its entirety.

 This manual reflects the equipment specifications and

applicable safety standards valid at the time of

printing. All rights are reserved for devices, circuits,

techniques, software programs, and names appearing

in this manual.

 On request GE Healthcare will provide a detailed

Service Manual.

 The safety information given in this manual is

classified as follows:

Danger

indicates an imminent hazard. If not avoided, the

hazard will result in death or serious injury.

Warning

indicates a hazard. If not avoided, the hazard can

result in death or serious injury.

Caution

indicates a potential hazard. If not avoided, the

hazard may result in minor injury and/or product/

property damage.

 To ensure patient safety and interference-free

operation and to guarantee the specified measuring

accuracy, we recommend only original equipment

accessories as available through GE Healthcare

distribution. The user is responsible for the

application of accessories from other manufacturers.

 The symbol means: Consult accompanying

documents. It indicates points which are of particular

importance in the operation of the equipment.

4 TONOPORT V 2001589-085 Revision F

PAR Medizintechnik GmbH & Co. KG

Sachsendamm 6

10829 Berlin

Germany

Tel. [phone]

Fax [phone]

Distributor:

GE Medical Systems

Information Technologies, Inc.

8200 West Tower Avenue

Milwaukee, WI 53223 USA

Tel: [phone]

1 800 437 1171 (USA only)

1 800 668 0732 (Canada only)

Fax: [phone]

General Information

The country of manufacture appears on the device label.

2001589-085 Revision F TONOPORT V 5

Application, Safety Information

1 Application, Safety Information

1.1 Application

Intended Use

TONOPORT V is a small-size, patient-borne blood

pressure monitor for ambulatory, non-invasive

measurement of the patient’s blood pressure. If the blood

pressure cuffs listed in chapter 10 "Order Information" fit

the patient, it can be used on adults, children, and small

children. TONOPORT V is not suitable for blood

pressure measurements in neonates. Also it is not

suitable for use in intensive-care medicine.

For periods of up to 30 hours, TONOPORT V records the

patient's blood pressure at selectable intervals and saves the

results. There is a choice of three different measurement

protocols.

Biocompatibility

The parts of the equipment described in this

manual, including all accessories, that come in

contact with the patient during the intended use,

fulfill the biocompatibility requirements of the

applicable standards if used as intended. If you

have questions in this matter, please contact GE

Healthcare or its representatives.

Oscillometric Measuring Method

The blood pressure is measured by the oscillometric

method. The criteria for this method are the pressure

pulsations superimposed with every systole on the air

pressure in the cuff.

Using TONOPORT V with CASE™ / CardioSoft

TONOPORT V can be operated in conjunction with

CASE

™

(version 5.15 or later) or with the analysis

program CardioSoft (version 4.14 or later) that is

included with TONOPORT V. If the USB port is

used (CardioSoft only), it is necessary to install the

appropriate driver first (see “Software Installation”

on page 23). With these systems, individual

measurement protocols can be created and the

stored data can be reviewed on-screen in tabular

and graphic form. With V6.5 and subsequent

versions, the patient ID used by the analysis

program can be stored in TONOPORT V to allow

the collected data to be downloaded without

selecting the patient first (

Operator Manuals; you will find the CardioSoft

manual on the CardioSoft CD

refer to the respective

).

The blood pressure cuff is wrapped around the upper arm

and inflated to a pressure which must be clearly above the

expected systolic pressure. A pressure transducer mea-

sures the cuff pressure as well as the superimposed pres-

sure pulsations. During blood pressure measurements the

cuff must be level with the heart. If this is not ensured,

the hydrostatic pressure of the liquid column in the blood

vessels will lead to incorrect results.

 When the patient is sitting or standing during

measurements, the cuff is automatically at the correct

level.

Fig. 1-1 Waveform representing the pressure decrease

in the cuff during a measurement: systolic

pressure at 131 mmHg, diastolic pressure at

76 mmHg

6 TONOPORT V 2001589-085 Revision F

Application, Safety Information

1.2 Functional Description

The TONOPORT V monitor accommodates the blood

pressure measuring system and a microprocessor for

system control and data processing. The monitor is

powered by two AA size batteries (either rechargeable

NiMH batteries or alkaline batteries).

2001589-085 Revision F TONOPORT V 7

1.3 Safety Information

Application, Safety Information

Danger

Risk to persons —

– The equipment is not designed for use in areas

where an explosion hazard may occur. Explosion

hazards may result from the use of flammable

anesthetic mixtures with air or with oxygen,

nitrous oxide, skin cleansing agents or

disinfectants.

Warning

Risk to persons —

–

Equipment may be connected to other

equipment or to parts of systems only when it

has been made certain that there is no danger to

the patient, the operator, or the environment as

a result. In those instances where there is any

element of doubt concerning the safety of

connected equipment, the user must contact the

manufacturers concerned or other informed

experts as to whether there is any possible

danger to the patient, the operator, or the

environment as a result of the proposed

combination of equipment. Compliance with the

standard IEC 60601-1 must always be ensured.

– TONOPORT V may be connected to CASE™ or to

a PC with the CardioSoft program. While

connected to any of these devices, TONOPORT V

must be disconnected from the patient.

–

Chemicals required for the maintenance of the

equipment, for instance, must under all

circumstances be prepared, stored, and kept at

hand in their specific containers. Failure to

observe this instruction may have severe

consequences for the patient.

–

The equipment has no protection against the

ingress of liquids. Liquids must not enter the

equipment. Equipment into which liquids have

entered must be inspected by a service

technician before use.

– Before cleaning, TONOPORT V must be

disconnected from other equipment (CASE

PC).

–

Dispose of the packaging material, observing

the applicable waste-control regulations. Keep

the packaging material out of children's reach.

™

,

8 TONOPORT V 2001589-085 Revision F

Application, Safety Information

Warning

Incorrect measurements —

–

Magnetic and electrical fields are capable of

interfering with the proper performance of the

equipment. For this reason make sure that

external equipment operated in the vicinity of

TONOPORT V complies with the relevant EMC

requirements. X-ray equipment, MRI devices,

radio systems, etc. are possible sources of

interference as they may emit higher levels of

electromagnetic radiation.

Caution

Equipment damage, risk to persons —

– Before connecting the battery charger to the

power line, check that the voltage ratings on the

nameplate match those of your local power line.

– The battery charger is not a medical device. It

must not be used in the patient environment.

– Before using the equipment, the operator is

required to ascertain that it is in correct working

order and operating condition.

– The operator must be trained in the use of the

equipment.

– Only persons who are trained in the use of

medical technical equipment and are capable of

applying it properly are authorized to apply such

equipment.

– There are no user-replaceable components

inside the equipment. Do not open. For service

or repair, please contact your local, authorized

dealer (http://gehealthcare.com).

2001589-085 Revision F TONOPORT V 9

Controls and Indicators

S

D

HR/min

-1

START

STOP

INFO

NBP

!

off 0

on I

TONOPORT V

1

2

3

4

8

11

10

9

6

5

7

INFO

INFO

INFO

START

STOP

2 Controls and Indicators

1 Connection for blood pressure cuff

2 Button : push to display the most recent

parameter readings. Readings appear in the

following order:

- systolic value "S" (unit mmHg or kPa shown on the

display)

- diastolic value "D" (unit mmHg or kPa shown on

the display)

- pulse rate "HR" (unit min

-1

)

The same button is used

- to toggle between the day phase and the night

phase chapter 4, section "Toggle Manually Between

Day and Night Phase") and

- to program the BP monitor (chapter 3 "Setup")

3 Button : push to start and stop a

measurement, and to confirm entries

4 Liquid crystal display (LCD)

5 Port for connection to PC (USB)

Fig. 2-1 TONOPORT V controls and indicators

Functions of the

Button

Message

Button

Function

on

display

Push once H 1 clear memory

Push twice H 2 set date and time

Push 3 times H 3 select the measurement

Push 4 times H 4 activate calibration mode

Push 5 times H 5 display firmware version

Push 6 times H 6 select energy source

Push 7 times H 7 enable/disable audio signal

Push 8 times H 8 toggle pressure unit between

protocol

mmHg and kPa

6 Port for connection to PC (RS232)

7 Calibration mark

8 Lid covering battery compartment

9 (Rechargeable) batteries

10 ON/OFF switch

11 Nameplate

10 TONOPORT V 2001589-085 Revision F

Controls and Indicators

0482

Explanation of Signs and Symbols

Symbols used on the equipment and on the packaging

For indoor use only

Caution, consult accompanying
documents

This symbol indicates that the waste of
electrical and electronic equipment must
not be disposed as unsorted municipal
waste and must be collected separately.
Please contact an authorized
representative of the manufacturer for
information concerning the
decommissioning of your equipment.

Type BF applied part
(defibrillation-proof)

Catalogue number

Serial number

CE marking

CE marked per the Medical Device
Directive 93/42/EEC of the European
Union. The notified body is MEDCERT
GmbH.

Manufacturer’s identification

Date of manufacture.
The number found under this symbol is
the date of manufacture in the YYYY­MM format.

Calibration mark, valid in Germany only
(see section "Technical Inspections of the
Measuring System" in chapter 8)

Symbols used on the display

M blinks with each detected oscillation; is

continuously lit when the monitor contains
data

blinks when the batteries are almost
depleted; is continuously displayed when
batteries are discharged and no more BP
measurements can be taken

day phase selected

night phase selected

Gossudarstwenny Standart Russia
(GOST)

In the USA, the product is only for use by
or on the order of a physician, or persons
licensed by U.S. law.

USB port, connection to PC

Serial port, connection to PC

Polarity of the DC input (charger only)

Approval mark for use of the equipment
in a vehicle (charger only, xxx-xx xxxx
alphanumeric characters)

Class II equipment

For indoor use only

Further relevant symbols used on the battery charger

TR15RA120
100-240V 0.4A
47-63Hz
12V 1.1A

Power supply type designation and
ratings

UL-certified product

Approval mark for Japan

Pollution control symbol according
to the Chinese standard SJ/T11363­2006

2001589-085 Revision F TONOPORT V 11

3Setup

START

STOP

INFO

START

STOP

INFO

START

STOP

START

STOP

INFO

START

STOP

START

STOP

INFO

START

STOP

INFO

START

STOP

Setup

Some Basic Facts on Battery Power

TONOPORT V is either powered by two rechargeable

Nickel Metal Hydrid batteries (NiMH) or by two alkaline

batteries. The device must be set to the power source used

(see section "Insert Batteries" below). The device also

contains a Lithium cell that powers the clock. The

Lithium cell can only be replaced by a service technician.

The capacity of two fully charged or new batteries is

sufficient for a minimum of 30 hours of operation or for

200 measurements.

The capacity of rechargeable batteries decreases with

age. If the capacity of fully charged batteries is

considerably less than 24 hours, the batteries must be

replaced.

Caution

Equipment damage —
– Only use the original rechargeable, size AA Nickel

Metal Hydrid batteries (from manufacturers such

as Sanyo, Panasonic, Energizer, Duracell, Varta,

or GP) with a capacity >

high-rate discharge alkaline batteries (such as

Panasonic Evoia, Energizer Ultimate, Duracell

Ultra, Duracell Power Pix, or Varta maxtech).

– Charge the NiMH batteries to capacity before

using them for the first time.

– Recharge the NiMH batteries immediately after

use and do not leave batteries uncharged.

– Use only the original charging unit to recharge

the NiMH batteries.

– Do not attempt to recharge the alkaline batteries.

1500 mAh or size AA

 Hold TONOPORT V as shown in Fig. 3-1 and slide

the lid of the battery compartment open (approx.

1cm).

Fig. 3-1 Opening the battery compartment

It is not possible to open the lid more than about 1 cm

which is just enough to reach the ON/OFF switch. To

replace batteries, you must take off the lid (pull upward).

 Place the two batteries in the compartment as indicat-

ed by the symbols.

Select Energy Source

 Turn on the BP monitor. The switch is located inside

the battery compartment. Slide the switch to the right,

while looking at the display.

 Wait for the time to be displayed.

– If the TONOPORT V will not be used for one

 Push six times: the display shows "H 6".

month or more, remove the (rechargeable)

batteries from the device.

– Batteries must not be disposed as unsorted

municipal waste and must be collected separately.

Please contact an authorized representative of the

 Push : the display will show "AAAA" when the

BP monitor is set up for rechargeable NiMH batteries

(as shipped) and "bbbb" when it is set up for alkaline

batteries.

manufacturer for information concerning the

decommissioning of the batteries.

 Confirm the displayed information with or

change the selection with and confirm the new

Insert Batteries

selection with .

Note

Switch TONOPORT V off before inserting the

batteries. To do so, slide the ON/OFF switch (10,

Fig. 2-1) to the left while looking at the display.

12 TONOPORT V 2001589-085 Revision F

 Next the BP monitor will briefly display the capacity

of the inserted batteries. "A 100", for instance, means

that the rechargeable batteries have a capacity of

100%, i.e., they are fully charged. "b 50" means that